Factorytalk, a leading digital solutions provider and consultancy for the life sciences industry, is thrilled to announce the successful upgrade and enhancement of Thailand’s electronic Common ...

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...

With the standard constantly evolving across the pharma sector, the latest version can help bring benefits to the regulatory process. The creation of the electronic common technical document (eCTD) ...

Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor. After a roundtable discussion on eCTD implementation that brought together ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...

How to cut time and cost by re-using already submitted documents. Increasing drug-development costs, patent expirations, and fewer blockbuster drugs in the pipeline are forcing life-science companies ...

Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND. Life science companies in today’s shrinking economy are looking for ways to maintain growth in the face of ...